None listed
Conditions
Brief summary
We conducted a trial to compare equivalence of 3 and 5 days of oral cotrimoxazole for treating WHO defined non-severe pneumonia and to study its effect on antimicrobial resistance development in nasopharyngeal Haemophilus influenzae and Streptococcus pneumoniae. The primary hypothesis was that a 3 day course was equivalent to the standard 5 day course of oral cotrimoxazole for the treatment of WHO defined non-severe pneumonia in children aged 2 – 59 months. The secondary hypotheses we tested were a) the relapse rate at 15 days did not differ between the two treatment groups and b) the longer course of antibiotic therapy led to an increased prevalence of S. pneumoniae and H. influenzae resistant to cotrimoxazole. The primary outcome was treatment failure at day 5 and the secondary outcome was relapse at day 15.
Interventions
Patient received two bottles, one with a green label contained cotrimoxazole, to be used during the first 3 days, and the second with a red label containing placebo, was used for the subsequent 2 days. Cotrimoxazole (40 mg trimethroprim + 200 mg sulphamethoxazole per 5 ml) was given in a dose of 4 mg/kg twice daily and prepared by SK&F Inc. in Bangladesh and Roche Inc. in Indonesia. The green-labels had six cells to be marked by the caretaker for the 6 doses in the first 3 days and the red labe
Patient received two bottles, one with a green label contained cotrimoxazole, to be used during the first 3 days, and the second with a red label containing placebo, was used for the subsequent 2 days. Cotrimoxazole (40 mg trimethroprim + 200 mg sulphamethoxazole per 5 ml) was given in a dose of 4 mg/kg twice daily and prepared by SK&F Inc. in Bangladesh and Roche Inc. in Indonesia. The green-labels had six cells to be marked by the caretaker for the 6 doses in the first 3 days and the red label had 4 cells to be marked for the next 2 days. A marked measuring cup was used to help dispense the dose. The first dose of cotrimoxazole was given by the caretaker under supervision at the health facility, with instructions given for the next doses, home care, follow-up visits and recognition of symptoms associated with very severe pneumonia. In Indonesia the second bottle was given to the caretaker on day 3 at a home visit, whereas in Bangladesh both bottles were given to the caretaker at enrollment. All of the treatments were consumed orally.
Sponsors
The University of Colorado at Denver and The Children’s Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
The inclusion criteria were: children aged 2-59 months with WHO defined non-severe pneumonia
Exclusion criteria
- children with WHO defined severe or very severe pneumonia or any other severe disease - children with a history of an allergic reaction to cotrimoxazole or three or more episodes of wheeze or current diagnosis of acute asthma - those who had been enrolled earlier in the study; required antibiotics for any other condition; had been hospitalized in the previous 2 weeks or who had severe malnutrition.
Outcome results
None listed